FDA Registration
Active
🇧🇷 Brazil
ALACER INDUSTRIA ELETRONICA LTDA
Reg #: 3016854619
·
FEI: 3016854619
·
Expires 2026
Products
4
Proprietary Names
180
Establishment Types
1
Classifications
4
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Registration Details
- Registration Name
- ALACER INDUSTRIA ELETRONICA LTDA
- Registration Number
- 3016854619
- FEI Number
- 3016854619
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Rua Batista de Melo 113, Jardim Jabaquara
- City
- Sao Paulo
- Country
- BR
Regulatory Submissions
- 510(k) Number
- K160170
Owner / Operator
- Firm Name
- ALACER INDUSTRIA ELETRONICA LTDA
- Operator Number
- 10086657
- Address
- Rua Batista de Melo 113, Jardim Jabaquara
- City
- Sao Paulo
- State
- BR-SP
- Postal Code
- 04383-080
- Country
- BR
- Correspondent
- Iracele Alkimim Sanches
US Agent
- Business Name
- Grupo Red International Corporation
- Contact Name
- Juan Caballero
- Address
- 1101 Brickell Ave
- City
- Miami
- State
- FL
- ZIP
- 33131
- Country
- US
- [email protected]
- Phone
- 786 7173600
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ph, Stomach | FFT | Class 1 | Gastroenterology, Urology | No | 2022-12-16 |
| Device, Cystometric, Hydraulic | FEN | Class 2 | Gastroenterology, Urology | No | 2024-01-12 |
| System, Gastrointestinal Motility (Electrical) | FFX | Class 2 | Gastroenterology, Urology | No | 2022-11-29 |
| System, Breath Measurement | NRH | Class 1 | Clinical Chemistry | No | 2024-02-29 |
Proprietary Names
AL-4 Catheter pHmetry Esophageal (2CpHAL4AD8cm)
AL-4 Catheter pHmetry Esophageal (3CpHAL4AD15-20cm)
pH Monitoring Probe (PH2C5CM)
pH Monitoring Probe (PH2C19CM)
AL-4 Catheter pHmetry Esophageal (2CpHAL4AD15cm)
AL-4 Catheter pHmetry Esophageal - External Reference (4PHAL4A101521UU)
pH Monitoring Probe (PH2C16CM)
AL-4 Catheter pHmetry Esophageal - External Reference (11PHAL4PD1,9UU)
AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD7CMUU)
AL-4 Catheter pHmetry Esophageal (1CpHAL4AD)
AL-4 Catheter pHmetry Esophageal - External Reference (4PHAL4A51520UU)
ZpH Catheter ImpedancepHmetry Esophageal - External Reference (1PH6Z20CMRE)
AL-4 Catheter pHmetry Esophageal (2CpHAL4AD20cm)
pH Monitoring Probe (PH3C-13-24CM)
pH Monitoring Probe (PH2C7CM)
ZpH Catheter ImpedancepHmetry Esophageal (1PH6Z7CMPDUU)
ZpH Catheter ImpedancepHmetry Esophageal (1PH6Z20CMUU)
ZpH Catheter ImpedancepHmetry Esophageal (IG2PH6Z16CMUU)
AL-4 Catheter pHmetry Esophageal - External Reference (1PHAL4AD1,4UU)
AL-4 Catheter pHmetry Esophageal (2CpHAL4AD12cm)
pH Monitoring Probe (PH2C17CM)
AL-4 Catheter pHmetry Esophageal (3CpHAL4AD7-23cm)
ZpH Catheter ImpedancepHmetry Esophageal - External Reference (IG2PH6Z14CMRE)
AL-4 Catheter pHmetry Esophageal (4CpHAL4AD101821)
AL-4 Catheter pHmetry Esophageal - External Reference (3PHAL4AD1520UU)
ZpH Catheter ImpedancepHmetry Esophageal - External Reference (1PH6Z22CMRE)
AL-4 Catheter pHmetry Esophageal - External Reference (3PHAL4AD1519UU)
pH Monitoring Probe (PH3C-7-23CM)
pH Monitoring Probe (PH1C-PED1,9)
AL-4 Catheter pHmetry Esophageal - External Reference (1PHAL4PD1,4UU)
ZpH Catheter ImpedancepHmetry Esophageal (IG2PH6Z12CMUU)
AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD18CMUU)
AL-4 Catheter pHmetry Esophageal (4CpHAL4AD51015cm)
ZpH Catheter ImpedancepHmetry Esophageal - External Reference (IG2PH6Z12CMRE)
ZpH Catheter ImpedancepHmetry Esophageal (1PH6Z10CMPDUU)
ZpH Catheter ImpedancepHmetry Esophageal - External Reference (2PH18_6Z18CMRE)
AL-4 Catheter pHmetry Esophageal (3CpHAL4AD13-24cm)
AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD21CMUU)
AL-4 Catheter pHmetry Esophageal (2CpHAL4AD5cm)
AL-4 Catheter pHmetry Esophageal (4CpHAL4AD101520)
AL-4 Catheter pHmetry Esophageal (1CpHAL4P1,9)
pH Monitoring Probe (PH2C10CM)
AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD10CMUU)
Electrolytic Gel for pHmetry and ZpH (ACAL122)
AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD15CMUU)
pH Monitoring Probe (PH2C13CM)
ZpH Catheter ImpedancepHmetry Esophageal - External Reference (IG2PH6Z16CMRE)
ZpH Catheter ImpedancepHmetry Esophageal - External Reference (1PH6Z16CMRE)
ZpH Catheter ImpedancepHmetry Esophageal (IG2PH6Z14CMUU)
ZpH Catheter ImpedancepHmetry Esophageal (1PH6Z22CMUU)
pH Monitoring Probe (PH2C18CM)
ZpH Catheter ImpedancepHmetry Esophageal - External Reference (IG2PH6Z20CMRE)
ZpH Catheter ImpedancepHmetry Esophageal - External Reference (1PH6Z10CMPDRE)
ZpH Catheter ImpedancepHmetry Esophageal - External Reference (1PH6Z14CMRE)
AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD11CMUU)
ZpH Catheter ImpedancepHmetry Esophageal - External Reference (2PH15_6Z15CMRE)
ZpH Catheter ImpedancepHmetry Esophageal - External Reference (1PH6Z12CMRE)
AL-4 Catheter pHmetry Esophageal - External Reference (3PHAL4AD1324UU)
AL-4 Catheter pHmetry Esophageal - External Reference (4PHAL4A51015UU)
AL-4 Catheter pHmetry Esophageal (2CpHAL4AD23cm)
AL-4 Catheter pHmetry Esophageal - External Reference (3PHAL4AD723UU)
ZpH Catheter ImpedancepHmetry Esophageal (1PH6Z12CMUU)
pH Monitoring Probe (PH2C15CM
ZpH Catheter ImpedancepHmetry Esophageal (1PH6Z18CMUU)
pH Monitoring Probe (PH3C-15-19CM)
AL-4 Catheter pHmetry Esophageal (2CpHAL4AD13cm)
pH 7 Buffer Solution
ZpH Catheter ImpedancepHmetry Esophageal (IG2PH6Z20CMUU)
pH Monitoring Probe (PH3C-15-20CM)
AL-4 Catheter pHmetry Esophageal (2CpHAL4AD21cm)
AL-4 Catheter pHmetry Esophageal - External Reference (4PHAL4A101520UU)
AL-4 Catheter pHmetry Esophageal (2CpHAL4AD11cm)
AL-4 Catheter pHmetry Esophageal (2CpHAL4AD10cm)
AL-4 Catheter pHmetry Esophageal (1CpHAL4AD1,4)
pH Monitoring Probe (PH2C12CM)
AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD20CMUU)
ZpH Catheter ImpedancepHmetry Esophageal - External Reference (1PH6Z18CMRE)
AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD12CMUU)
pH Monitoring Probe (PH1CAD)
AL-4 Catheter pHmetry Esophageal (4CpHAL4AD51520cm)
AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD8CMUU)
AL-4 Catheter pHmetry Esophageal (1CpHAL4P1,4)
AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD5CMUU)
AL-4 Catheter pHmetry Esophageal (2CpHAL4AD7cm)
ZpH Catheter ImpedancepHmetry Esophageal (2PH18_6Z18CMUU)
pH Monitoring Probe (PH2C21CM)
AL-4 Catheter pHmetry Esophageal - External Reference (1PHAL4ADUU)
AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD13CMUU)
pH Monitoring Probe (PH3C-15-18CM)
AL-4 Equipment for Impedance-pHmetry Esophageal (AL-4 pH; AL-4 ZpH)
AL-4 Catheter pHmetry Esophageal (4CpHAL4AD101521)
pH Monitoring Probe (PH2C8CM)
pH Monitoring Probe (PH2C20CM)
ZpH Catheter ImpedancepHmetry Esophageal (2PH15_6Z15CMUU)
AL-4 Catheter pHmetry Esophageal (3CpHAL4AD15-19cm)
AL-4 Catheter pHmetry Esophageal (2CpHAL4AD18cm)
ZpH Catheter ImpedancepHmetry Esophageal (IG2PH6Z18CMUU)
ZpH Catheter ImpedancepHmetry Esophageal - External Reference (1PH6Z7CMPDRE)
AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD23CMUU)
AL-4 Catheter pHmetry Esophageal - External Reference (4PHAL4A101821UU)
pH 1 Buffer Solution
AL-4 Catheter pHmetry Esophageal (3CpHAL4AD15-18cm)
AL-4 Catheter pHmetry Esophageal - External Reference (3PHAL4AD1518UU)
pH Monitoring Probe (PH1C-PED1,4)
ZpH Catheter ImpedancepHmetry Esophageal - External Reference (IG2PH6Z18CMRE)
ZpH Catheter ImpedancepHmetry Esophageal (1PH6Z14CMUU)
ZpH Catheter ImpedancepHmetry Esophageal (1PH6Z16CMUU )
BP-1 Urodynamics Infusion Pump - Peristaltic Pump
PVC Rectal Balloon Probe (SDBL10PVC42; SDBL12PVC42; SDBL10PVC124; SDBL12PVC124)
Silicone Tube for Infusion Mechanisms (DUCTUB001)
UROCOMMANDER Equipment with EMG
Biofeedback Balloon Probe (SB-BIO)
Double Lumen Pig Tail Probe (4.1860B; SDL-PG-6FR; SDL-PG-7FR; SDL-PG-8FR)
Connector for Minimally Invasive Male Urodynamics (DUAUMI)
Infusion Set for Urodynamics Infusion Pump (EQUIPOBP1)
UROCOMMANDER Equipment for Flowmetry
UROCOMMANDER Equipment for Urodynamics
Urodynamics Catheter Extender (EXTUR10FR120)
Rectal Balloon Probe (B08FR-4; B10FR-4; B12FR-4)
Double Lumen Probe (DL6FR; DL6FR-2F; DL6FR-30; DL7FR; DLFR8)
UROCOMMANDER Equipment for Flowmetry Uroflow
UROCOMMANDER Equipment for Biofeedback
CFE-P-26C4.3-0.5; CFE-P-26C4.3-0.7; CFE-P-26C4.7-0.5; CFE-P-26C4.7-0.7; CFE-P-28C3.2-0.5; CFE-P-28C3.2-0.7;
CFE-P-30C3.2-0.5; CFE-P-30C3.2-0.7; CFE-P-30C4.2-0.5; CFE-P-30C4.2-0.7; CFE-P-30C4.3-0.5; CFE-P-30C4.3-0.7;
CFE-P-18C4.3-0.7-20cm; CFE-P-18C4.3-0.7-21cm; CFE-P-18C4.3-0.7-25cm; CFE-P-18C4.3-0.7-30cm; CFE-P-18C4.7-0.5-20cm;
CFE-P-18C3.2-0.7-21cm; CFE-P-18C3.2-0.7-25cm; CFE-P-18C3.2-0.7-30cm; CFE-P-18C4.2-0.5-20cm; CFE-P-18C4.2-0.5-21cm;
CFA-P-36C-4.7-6cm/RD2
CFA-P-12C-4.7-6cm/RD1; CFA-P-12C-4.7-6cm/SP1; CFA-P-14C-4.7-3cm; CFA-P-14C-4.7-4.5cm; CFA-P-14C-4.7-6cm;
CFA-P-20C-4.7-6cm; CFA-P-22C-4.7-3cm; CFA-P-22C-4.7-4.5cm; CFA-P-22C-4.7-6cm; CFA-P-24V4; CFA-P-24V4.7;
CFA-P-28C-4.7-6cm; CFA-P-30C-4.7-3cm; CFA-P-30C-4.7-4.5cm; CFA-P-30C-4.7-6cm; CFA-P-32C-4.7-3cm;
Anorectal Easy Connect Catheters - 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36 Channels (CFA)
CFE-P-30C4.7-0.5; CFE-P-30C4.7-0.7; CFE-P-32C3.2-0.5; CFE-P-32C3.2-0.7; CFE-P-32C4.2-0.5; CFE-P-32C4.2-0.7;
CFA-P-24C-4.7-3cm; CFA-P-24C-4.7-4.5cm; CFA-P-24C-4.7-6cm; CFA-P-24C-4.7-6cm/RD1; CFA-P-24C-4.7-6cm/RD2;
CFE-P-36C3.2-0.7-21cm; CFE-P-36C3.2-0.7-25cm; CFE-P-36C3.2-0.7-30cm; CFE-P-36C4.2-0.5-20cm; CFE-P-36C4.2-0.5-21cm;
CFE-P-22C4.2-0.5; CFE-P-22C4.2-0.7; CFE-P-22C4.3-0.5; CFE-P-22C4.3-0.7; CFE-P-22C4.7-0.5; CFE-P-22C4.7-0.7;
CFA-P-2C-4.7; CFA-P-2C-4; CFA-P-4C-4.7; CFA-P-4C-4; CFA-P-6C-4.7; CFA-P-6C-4; CFA-P-8C-4.7; CFA-P-8C-4;
CFE-P-18C4.7-0.7-25cm; CFE-P-18C4.7-0.7-30cm; CFE-P-20C3.2-0.5; CFE-P-20C3.2-0.7; CFE-P-20C4.2-0.5; CFE-P-20C4.2-0.7;
CFE-P-24C3.2-0.5-20cm; CFE-P-24C3.2-0.5-21cm; CFE-P-24C3.2-0.5-25cm; CFE-P-24C3.2-0.5-30cm; CFE-P-24C3.2-0.7-20cm;
CFE-P-36C4.7-0.7-25cm; CFE-P-36C4.7-0.7-30cm
CFE-P-18C4.2-0.7-30cm; CFE-P-18C4.3-0.5-20cm; CFE-P-18C4.3-0.5-21cm; CFE-P-18C4.3-0.5-25cm; CFE-P-18C4.3-0.5-30cm;
CFE-P-12C3.2-0.5; CFE-P-12C3.2-0.7; CFE-P-12C4.2-0.5; CFE-P-12C4.2-0.7; CFE-P-12C4.3-0.5; CFE-P-12C4.3-0.7;
CFA-P-10C-4.7; CFA-P-10C-4; CFA-P-12V4.7; CFA-P-12V4; CFA-P-12C-4.7-3cm; CFA-P-12C-4.7-4.5cm;
Catheter Washer (LAVCAT-8CMU; LAVCAT-24CMU; LAVCAT-36CMU)
CFE-P-14C4.3-0.5; CFE-P-14C4.3-0.7; CFE-P-14C4.7-0.5; CFE-P-14C4.7-0.7; CFE-P-16C3.2-0.5; CFE-P-16C3.2-0.7;
CFE-P-24C4.2-0.7-30cm; CFE-P-24C4.3-0.5-20cm; CFE-P-24C4.3-0.5-21cm; CFE-P-24C4.3-0.5-25cm; CFE-P-24C4.3-0.5-30cm;
CFE-P-24C3.2-0.7-21cm; CFE-P-24C3.2-0.7-25cm; CFE-P-24C3.2-0.7-30cm; CFE-P-24C4.2-0.5-20cm; CFE-P-24C4.2-0.5-21cm;
CFE-P-16C4.2-0.5; CFE-P-16C4.2-0.7; CFE-P-16C4.3-0.5; CFE-P-16C4.3-0.7; CFE-P-16C4.7-0.5; CFE-P-16C4.7-0.7;
CFA-P-36V4.7; CFA-P-36C-4.7-3cm; CFA-P-36C-4.7-4.5cm; CFA-P-36C-4.7-6cm; CFA-P-36C-4.7-6cm/RD1;
CFE-P-36C4.2-0.7-30cm; CFE-P-36C4.3-0.5-20cm; CFE-P-36C4.3-0.5-21cm; CFE-P-36C4.3-0.5-25cm; CFE-P-36C4.3-0.5-30cm;
CFE-P-32C4.3-0.5; CFE-P-32C4.3-0.7; CFE-P-32C4.7-0.5; CFE-P-32C4.7-0.7; CFE-P-34C3.2-0.5; CFE-P-34C3.2-0.7;
Esophageal Easy Connect Catheters - 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36 (CFE)
CFE-P-2C4.7-0.7; CFE-P-4C3.2-0.5; CFE-P-4C3.2-0.7; CFE-P-4C4.2-0.5; CFE-P-4C4.2-0.7; CFE-P-4C4.3-0.5; CFE-P-4C4.3-0.7;
CFE-P-24C4.2-0.5-25cm; CFE-P-24C4.2-0.5-30cm; CFE-P-24C4.2-0.7-20cm; CFE-P-24C4.2-0.7-21cm; CFE-P-24C4.2-0.7-25cm;
CFE-P-36C4.2-0.5-25cm; CFE-P-36C4.2-0.5-30cm; CFE-P-36C4.2-0.7-20cm; CFE-P-36C4.2-0.7-21cm; CFE-P-36C4.2-0.7-25cm;
CFE-P-2C3.2-0.5; CFE-P-2C3.2-0.7; CFE-P-2C4.2-0.5; CFE-P-2C4.2-0.7; CFE-P-2C4.3-0.5; CFE-P-2C4.3-0.7; CFE-P-2C4.7-0.5;
CFE-P-36C4.7-0.5-21cm; CFE-P-36C4.7-0.5-25cm; CFE-P-36C4.7-0.5-30cm; CFE-P-36C4.7-0.7-20cm; CFE-P-36C4.7-0.7-21cm;
CFE-P-18C3.2-0.5-20cm; CFE-P-18C3.2-0.5-21cm; CFE-P-18C3.2-0.5-25cm; CFE-P-18C3.2-0.5-30cm; CFE-P-18C3.2-0.7-20cm;
CFE-P-12C4.7-0.5; CFE-P-12C4.7-0.7; CFE-P-14C3.2-0.5; CFE-P-14C3.2-0.7; CFE-P-14C4.2-0.5; CFE-P-14C4.2-0.7;
CFE-P-10C4.2-0.5; CFE-P-10C4.2-0.7; CFE-P-10C4.3-0.5; CFE-P-10C4.3-0.7; CFE-P-10C4.7-0.5; CFE-P-10C4.7-0.7;
CFE-P-28C4.2-0.5; CFE-P-28C4.2-0.7; CFE-P-28C4.3-0.5; CFE-P-28C4.3-0.7; CFE-P-28C4.7-0.5; CFE-P-28C4.7-0.7;
CFE-P-4C4.7-0.5; CFE-P-4C4.7-0.7; CFE-P-6C3.2-0.5; CFE-P-6C3.2-0.7; CFE-P-6C4.2-0.5; CFE-P-6C4.2-0.7; CFE-P-6C4.3-0.5;
CFE-P-20C4.3-0.5; CFE-P-20C4.3-0.7; CFE-P-20C4.7-0.5; CFE-P-20C4.7-0.7; CFE-P-22C3.2-0.5; CFE-P-22C3.2-0.7;
CFA-P-26C-4.7-3cm; CFA-P-26C-4.7-4.5cm; CFA-P-26C-4.7-6cm; CFA-P-28C-4.7-3cm; CFA-P-28C-4.7-4.5cm;
CFE-P-36C3.2-0.5-20cm; CFE-P-36C3.2-0.5-21cm; CFE-P-36C3.2-0.5-25cm; CFE-P-36C3.2-0.5-30cm; CFE-P-36C3.2-0.7-20cm;
CFA-P-18C-4.7-6cm/RD1; CFA-P-18C-4.7-6cm/RD2; CFA-P-18C-4.7-6cm/SP1; CFA-P-20C-4.7-3cm; CFA-P-20C-4.7-4.5cm;
CFE-P-8C4.3-0.5; CFE-P-8C4.3-0.7; CFE-P-8C4.7-0.5; CFE-P-8C4.7-0.7; CFE-P-10C3.2-0.5; CFE-P-10C3.2-0.7;
CFE-P-6C4.3-0.7; CFE-P-6C4.7-0.5; CFE-P-6C4.7-0.7; CFE-P-8C3.2-0.5; CFE-P-8C3.2-0.7; CFE-P-8C4.2-0.5; CFE-P-8C4.2-0.7;
Single Connector Multiway (CUM8V; CUM12V; CUM24V; CUM36V; TP1; TP2)
CFE-P-34C4.2-0.5; CFE-P-34C4.2-0.7; CFE-P-34C4.3-0.5; CFE-P-34C4.3-0.7; CFE-P-34C4.7-0.5; CFE-P-34C4.7-0.7;
CFE-P-36C4.3-0.7-20cm; CFE-P-36C4.3-0.7-21cm; CFE-P-36C4.3-0.7-25cm; CFE-P-36C4.3-0.7-30cm; CFE-P-36C4.7-0.5-20cm;
CFA-P-32C-4.7-4.5cm; CFA-P-32C-4.7-6cm; CFA-P-34C-4.7-3cm; CFA-P-34C-4.7-4.5cm; CFA-P-34C-4.7-6cm; CFA-P-36V4;
CFE-P-24C4.3-0.7-20cm; CFE-P-24C4.3-0.7-21cm; CFE-P-24C4.3-0.7-25cm; CFE-P-24C4.3-0.7-30cm; CFE-P-24C4.7-0.5-20cm;
CFA-P-16C-4.7-3cm; CFA-P-16C-4.7-4.5cm; CFA-P-16C-4.7-6cm; CFA-P-18C-4.7-3cm; CFA-P-18C-4.7-4.5cm;
CFE-P-18C4.2-0.5-25cm; CFE-P-18C4.2-0.5-30cm; CFE-P-18C4.2-0.7-20cm; CFE-P-18C4.2-0.7-21cm; CFE-P-18C4.2-0.7-25cm;
CFE-P-24C4.7-0.5-21cm; CFE-P-24C4.7-0.5-25cm; CFE-P-24C4.7-0.5-30cm; CFE-P-24C4.7-0.7-20cm; CFE-P-24C4.7-0.7-21cm;
CFE-P-18C4.7-0.5-21cm; CFE-P-18C4.7-0.5-25cm; CFE-P-18C4.7-0.5-30cm; CFE-P-18C4.7-0.7-20cm; CFE-P-18C4.7-0.7-21cm;
CFE-P-24C4.7-0.7-25cm; CFE-P-24C4.7-0.7-30cm; CFE-P-26C3.2-0.5; CFE-P-26C3.2-0.7; CFE-P-26C4.2-0.5; CFE-P-26C4.2-0.7;
H2X Hydrogen Breath Analyzer
MULTIPLEX 8; MULTIPLEX 12; MULTIPLEX 18; MULTIPLEX 24; MULTIPLEX 36
MULTIPLEX High-Resolution Esophageal/Anorectal Manometry Equipment
Establishment Types
Manufacture Medical Device